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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA explained in its 12 July Federal Register posting that while the meetings themselves have been common for quite some time, the scope of the guidance has remained unchanged since 1995 and is in dire need of an update to reflect its broader scope and incorporate additional changes.

From Pre-IDE to Pre-Sub: The New Program

Other planned changes include providing guidance on whether a clinical study requires an IDE, covering medical devices regulated by FDA's Center for Biologics Evaluation and Research (CBER), and a name change for the program.

The program, formerly known as the Pre-IDE program, will instead be called the Pre-Submission (Pre-Sub) program, though its purpose will remain largely the same, FDA said.

"The main purpose of the Pre-Sub program remains the same as the pre-IDE program: to facilitate providing advice to applicants when they have specific questions during product development and early protocol planning, about device studies that present significant risk(s) (SR) as well as non-significant risk(s) (NSR) or when developing protocols for clinical studies conducted outside of the United States to support future U.S. marketing applications," FDA wrote.

"Consequently, the Pre-Sub program can provide an efficient path from device concept to market," it concluded.

'Best Possible Advice'

Included in the draft guidance is information pertaining to the best types of information to include with pre-submission dossiers, an outline of FDA's preferred process for when to schedule Pre-Sub meetings, and its expectations for the advice it dispenses to applicants.

"FDA intends to provide the best possible advice in accordance with the information provided, ensure it is captured accurately in the meeting minutes drafted by the sponsor, and commit to that advice unless the circumstances sufficiently change such that our advice is no longer applicable, such as when a sponsor changes the intended use of their device after we provide feedback," the agency explained in the Federal Register posting.

FDA notes its ability to hold meetings is largely contingent upon its resources, which are often strained. The agency estimates the Center for Devices and Radiological Health (CDRH) will receive more than 2,400 Pre-Sub meeting requests, while CBER will receive 79. Each meeting is estimates to involve 137 hours of work per applicant.